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Use of Ceftaroline 30μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30μg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic. Active In Vitro and in Clinical Infections Against: Gram-positive Microorganisms Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae Gram-negative Microorganisms Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae Active In Vitro Against: Gram-positive Microorganisms Streptococcus dysgalactiae Gram-negative Microorganisms Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis Haemophilus parainfluenzae

Ceftaroline 30ug BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Ceftaroline supplied by the drug manufacturer. Each Ceftaroline disk is clearly marked on both sides with the agent and drug content. Ceftaroline cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ceftaroline disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method. Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Aqar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.

The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a luer connector, The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and luer adapter are color-coded.

BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peelaway (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized. The purpose of the 510(k) is to expand the needle range to include the 23G x 7 mm pen needle size. Future needle range expansions may include 24G to 28G in various lengths for which appropriate verification and validation activities will be conducted. The intended use for the modified device remains the same as the predicate device.

The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD RST is not recommended for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency.

BD Vacutainer® Tubes are sterile, single-use, evacuated plastic blood collection tubes with rubber stoppers that provide a means of collecting, transporting, separating, and processing blood in a closed tube. The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) clots blood specimens much faster than other additives (5 minutes), and therefore is desirable when a fast turn-around-time is necessary.